Merck’s Vioxx, a nonsteroidal anti-inflammatory (NSAID) painkiller, made headlines in 2004 when the company voluntarily withdrew it from the U.S. market following reports of increased rates of strokes and heart attacks in patients taking the drug chronically. Vioxx was the most famous of more than a dozen drugs withdrawn from the market since 2000.
But withdrawal of drugs is not a new phenomenon. In fact, the Food and Drug Administration (FDA) took on its modern form as a reaction to the horrific side effects of the drug thalidomide, introduced in Europe in the 1950s as a sleep aid and treatment for morning sickness in pregnant women.
By 1962, it was evident that thalidomide caused severe limb deformities, and Frances Kelsey, the FDA’s medical officer at the time, kept the drug off of the market. In Europe, 8,000 babies were born with defects resulting from the drug. That tragedy prompted a Congressional bill that gave the FDA the authority to raise the safety bar and require that companies prove the effectiveness of drugs before they could be marketed in the United States.
Recently, the FDA has come under attack for not living up to its mission. The agency failed to catch serious side effects in a number of drugs before they were approved, thus forcing embarrassing withdrawals.
Critics attribute these failures to the agency’s close ties with the medical industry. These close ties are exemplified by the 1992 Prescription Drug User Fees Act, which requires industry to pay user fees that help fund the agency’s review of new drugs for approval.
Part of the purpose of the legislation was to shorten the approval times and get drugs to market more quickly. But according to a 2002 report by the Government Accounting Office (GAO), the legislation ultimately caused increased workload for the FDA’s reviewers. There was also a slight increase in the percentage of drugs that had to be withdrawn from the market.
The side effect of withdrawing drugs
The flip side of the decision to withdraw a drug due to rare, serious side effects is that it can leave some patients with few therapeutic options. For example, some patients objected to the withdrawal of Zelnorm, a drug used to treat irritable bowel syndrome.
Seriously ill patients “should be able to take a risk,” says Peter Barton Hutt, senior counsel at the law firm Covington & Burling LLP, and former FDA chief counsel.
But Diana Zuckerman, president of the National Research Center for Women & Families, argues that it isn’t that simple.
“The problem is that patients aren’t really told ([about a drug’s risks). Doctors aren’t giving that information, partly because they don’t spend that much time with patients and partly because they don’t know themselves—they haven’t read all 10 studies (performed on a drug).”
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